On June 2, 2023, the Centers for Medicare & Medicaid Services (CMS) issued instructions for the process by which a manufacturer may submit a request for a qualifying single-source drug to be ...
On Friday, August 4 th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section ...
Agency: "Centers for Medicare & Medicaid Services (CMS), HHS." SUMMARY: This final notice announces our decision to approve the request of St. James Behavioral Health Hospital Inc for an exception to ...
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